AIBRIEF
The 1,137 patient melanoma trial met both main pre specified goals at a planned mid trial analysis, but the companies did not release effect size numbers; full data is expected at an upcoming medical conference.
Moderna and Merck said Wednesday that a personalized mRNA cancer vaccine, built from up to 34 mutations in a single patient's tumor, met both primary goals of a 1,137-patient Phase 3 melanoma trial at a planned interim analysis. It's the first late-stage readout for a treatment class designed and manufactured for one person at a time.
The trial, called INTerpath-001, randomized patients with completely resected Stage IIB–IV melanoma 2:1 to receive the vaccine (intismeran autogene, also called mRNA-4157) plus Merck's Keytruda, or Keytruda alone. The combination extended recurrence-free survival and distant metastasis-free survival, the companies said. Specific effect-size numbers were not released; both companies said the data will be presented at an upcoming international medical conference.
The vaccine works by sequencing a patient's tumor and healthy DNA, identifying up to 34 neoantigens, and manufacturing a bespoke mRNA shot for that individual.
The only specific numbers in the public record, a 49% reduction in recurrence or death and a 59% reduction in distant metastasis or death, come from a separate five-year follow-up of the smaller Phase 2b KEYNOTE-942 trial, not from INTerpath-001. An exploratory overall-survival confidence interval from that 5-year data crossed 1.0, so a survival benefit cannot yet be claimed.
Ars Technica flagged the missing magnitude, subgroup, and quality-of-life data.